Vitamin D3 Supplementation at 4000 International Units Per Day for One Year Results in a Decrease of Positive Cores at Repeat Biopsy in Subjects with Low-Risk Prostate Cancer under Active Surveillance

• Published in: The journal of clinical endocrinology and metabolism Vol. 97; no. 7; pp. 2315 - 2324
• Main Authors: Marshall, David T., Savage, Stephen J., Garrett-Mayer, Elizabeth, Keane, Thomas E., Hollis, Bruce W., Horst, Ronald L., Ambrose, Linda H., Kindy, Mark S., Gattoni-Celli, Sebastiano
• Format: Journal Article
• Language: English
• Published: Bethesda, MD Oxford University Press 01.07.2012; Copyright by The Endocrine Society; Endocrine Society
• Subjects: Adverse events; Aged; Biological and medical sciences; Biopsy; Biopsy, Fine-Needle; Carcinoma - diet therapy; Carcinoma - etiology; Carcinoma - pathology; Carcinoma - prevention & control; Cholecalciferol - administration & dosage; Cholecalciferol - pharmacology; Dietary Supplements; Dose-Response Relationship, Drug; Down-Regulation; Drug development; Endocrine Care; Endocrinopathies; Feeding. Feeding behavior; Fundamental and applied biological sciences. Psychology; Humans; International System of Units; Male; Medical sciences; Middle Aged; Patients; Population Surveillance; Prostate - pathology; Prostate cancer; Prostate-specific antigen; Prostatic Neoplasms - diet therapy; Prostatic Neoplasms - etiology; Prostatic Neoplasms - pathology; Prostatic Neoplasms - prevention & control; Risk Factors; Serum levels; Surveillance; Time Factors; Treatment Outcome; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Vertebrates: endocrinology; Vitamin D; Vitamin D3; Watchful Waiting - methods; World; Human; Obesity; Urinary system disease; Prostate disease; Nutrition; Nutrition disorder; Metabolic diseases; Malignant tumor; Low risk; Result; Surveillance; Vitamin D; Biopsy; Supplementation; Male genital diseases; Prostate cancer; Endocrinology; Nutritional status; Cancer; Colecalciferol; International
• DOI: 10.1210/jc.2012-1451
• ISSN: 0021-972X; 1945-7197

Context:We wanted to investigate vitamin D in low-risk prostate cancer.Objectives:The objective of the study was to determine whether vitamin D3 supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.Design:In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.Setting:All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.Patients and Other Participants:All subjects had a diagnosis of low-risk prostate cancer. Fifty-two subjects were enrolled in the study, 48 completed 1 yr of supplementation, and 44 could be analyzed for both safety and efficacy objectives.Intervention:The intervention included vitamin D3 soft gels (4000 IU).Main Outcome Measures:Adverse events were monitored throughout the study. PSA serum levels were measured at entry and every 2 months for 1 yr. Biopsy procedures were performed before enrollment (for eligibility) and after 1 yr of supplementation.Results:No adverse events associated with vitamin D3 supplementation were observed. No significant changes in PSA levels were observed. However, 24 of 44 subjects (55%) showed a decrease in the number of positive cores or decrease in Gleason score; five subjects (11%) showed no change; 15 subjects (34%) showed an increase in the number of positive cores or Gleason score.Conclusion:Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D3 supplementation at 4000 IU/d.